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SECURE-C Cervical Artificial Disc

by Globus Medical, Inc.

PMA P100003

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P100003↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP100003 Date28 Sep 2012ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade name
Secure-C Artificial Cervical Disc
Generic name
Prosthesis, intervertebral disc
PMA number
FDA product code
MJO
Device class
Class III
Advisory committee
Orthopedic
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SECURE-C Cervical Artificial Disc is a prosthesis, intervertebral disc designed for reconstruction of the disc at one level from C3-C7 following single-level discectomy. It is indicated in skeletally mature patients with intractable radiculopathy, myelopathy, or neck pain due to single-level disc abnormalities confirmed by radiographic imaging.

This device is implanted using an anterior approach after at least six weeks of failed conservative treatment. It is supplied as a sterile, single-use implant and is authorized under FDA PMA P100003. The device is classified as Class III and is intended for use in surgical settings by qualified physicians.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What levels of the cervical spine is the SECURE-C Cervical Artificial Disc indicated for?

    The SECURE-C Cervical Artificial Disc is indicated for reconstruction of the disc at one level from C3-C7 following single-level discectomy, as specified in the device's approval statement.

  • What conditions must be present to justify implantation of the SECURE-C Cervical Artificial Disc?

    Implantation is justified when there is a single-level abnormality localized to the disc space confirmed by radiographic imaging (CT, MRI, or X-rays), including herniated nucleus pulposus, spondylosis (defined by osteophytes), and/or visible loss of disc height compared to adjacent levels.

  • Is the SECURE-C Cervical Artificial Disc reusable or single-use?

    The SECURE-C Cervical Artificial Disc is supplied as a sterile, single-use implant, as indicated by its classification and authorization details in the device data.